From October 2016 to March 2017 the team is joined by Guest Kats Rosie Burbidge and Eibhlin Vardy, and by InternKats Verónica Rodríguez Arguijo, Tian Lu and Hayleigh Bosher.

Saturday, 20 September 2014

AIPPI Congress Report 7: The one where the second medical use resolution is adopted

As much as the AmeriKat adores
administrative AIPPI issues, a much needed
bubble bath was required in preparation for
the Gala Dinner
After an intense morning of IPKat posting and editing, the AmeriKat wandered down to the final Executive Committee (ExCo) with a creamy Second Cup chai tea latte in her paw.  As she walked in, she noted a distinct lack of energy amongst the audience.  It could have been because many were still recovering from their Tuesday late night parties or because they were still in the midst of the first of two hours of administrative issues that needed to be discussed.  Whatever it was, the AmeriKat decided that further Kat posts and some client meetings required her attention (as well as a rare relaxing bath before the Gala Dinner).  In her absence, the AmeriKat's colleague Eibhlin Vardy continues her report on the fate of the second medical use question in the plenary and Wednesday's ExCo:  
"The plenary session on Q238: “Second medical use and other second indication claims” was chaired by Ian Karet (Linklaters, UK), who used humour and diplomacy to maintain authority over the AIPPI troops in attendance.

Claire Baldock (Boult Wade Tennant, UK) introduced the session by outlining the tremendous patient benefit that can be achieved from incremental innovation such as a second medical use discovery. Second medical use drugs have the added benefit that their toxicology profile is likely to have already been assessed for previous indications, and much more will be known about the drug than new compounds. Despite these benefits, significant enforcement challenges remain, and it can difficult to determine when a second medical use claim has been infringed.
Sarah Matheson (Allens, Australia) gave an overview of the 43 national reports that were submitted on Q238. These reports are available on the AIPPI website. The national reports formed the basis for the proposed resolution.

Around 85% of reports confirmed that some form of second medical use claims were permitted. There was more controversy as regards the permissibility of certain types of claim, such as new dosage regimes, or a patient class. Most jurisdictions reported some limitation on the form of claims allowed, with 75% allowing EPC 2000 style purpose limited product claims, in comparison with only 35% for Swiss form claims.

In relation to identifying the particular parties who might be liable for infringement of a full label product that explicitly covers a patented second medical use, 100% of jurisdictions reported that the drug manufacturer would be liable. By way of comparison, 80% of jurisdictions were of the view that dispensing pharmacists would be liable, 45% of jurisdictions thought that the prescribing physician would be liable and 12.5% of jurisdictions were of the opinion that the patient would be liable.  However, Matheson noted that there were significant grey areas in these responses, and many jurisdictions did not have case law on these specific issues. 95% of responses agreed that harmonisation was desirable, and many emphasized the need for the regulatory framework and patent law to operate together. Another key theme included uncertainty regarding enforcement by patentees in relation to skinny label products, with a carve out for the patented indication.

Andri Hess (Homburger, Switzerland) who chaired the working committee explained that every resolution had passed in the working committee with very high majorities. The resolution is broadly composed of three parts: (1) patent eligible subject matter; (2) infringement; and (3) regulatory issues. 
Several amendments were proposed in the plenary session, including a request from the French delegation to delete paragraph 12 which provides that "injunctive relief for infringement of a patented second medical use should not be denied solely because such relief could prevent a pharmaceutical from being commercialised for non-patented uses. Consideration should be given to all the circumstances of the case, including the interests of the involved parties”. The concern was that the resolution did not give Courts sufficient discretion to refuse an injunction. However, the proposed amendment was rejected, suggesting that the wording was sufficiently flexible to refuse an injunction if that was appropriate on the facts of a particular case.

The final resolution on Q238 was adopted at the Executive Committee session on Wednesday afternoon, with 185 votes in favour, 4 against, and 4 abstentions.

This writer wonders whether the final resolution will be used by international or national AIPPI groups to bring these issues to the attention of the relevant authorities and, as a consequence, whether the authorities will take any action."


Anonymous said...

This is a highly political issue because second medical use claims can be used for evergreening, effectively extending protection for a pharmaceutical product beyond the initial patent term. It is unfortunate that the resolution does not acknowledge or discuss that.

Anonymous said...

A discussion on ever greening would be helpful.

Isn't one understated aspect of those that disfavor "ever greening" the fact that what is prolonged is NOT the original patent item and merely those items that are patentedly distinct - bu that have become the desired item over time?

Is not the base item that becomes a part of the public domain STILL a part of the public domain, open to any who wish to pursue that base item (without the new improvements?)

Is this not how it should be?

SO yes, I for one would enjoy a discussion on exactly what is this "ever greening" unfairness that is implied, but not quite made explicit.

Anonymous said...

Don't be silly. Evergreening is all about extending the original monopoly of those unworthy pharmaceutical firms at the expense of the kind-hearted generics who exist solely for the benefit of mankind. Where would hose poor patients be without them? Probably not as dead as they would be if it were not for those greedy pharma guys.

Anonymous said...

Well anonymous of 8:54, I notice that CIPA Congress is going to discuss the issue of how pharma uses its IP. I hope that will be constructive discussion which will lead to solutions for how to address this problem.

Anonymous said...

Who says there is a problem?

I fancy a new abode. You won't mind if I break into your house and make myself at home, I presume?

Oxfam should focus their time on developing sanitation and supplies of clean water to the poor, rather than jetting around posh hotels chatting about bigpharma being evil.

Anonymous said...

I was hoping for a discussion on evergreening - not rhetoric on the "evils" of pharma.

I will ask again: How is evergreening an actual problem? Is not the base patent turned into public domain property at the end of the patent term - regardless of ANY add-on patents? Surely, no add-on patent can affect the term of the first patent.

Yes, I can see that the public domain does not obtain the improved features of the add-on patents, but so what? The benefit of the bargain in the first patent exchange of Quid Pro Quo is surely there. Or is the premise that even the first exchange cannot be achieved because of the add-on patents?

Anonymous said...

I'm not an expert in evergreening but I believe one of the worst cases was Les Laboratoires Servier and Servier Laboratories Limited v Apotex Inc, Apotex Pharmachem Inc Apotex Europe Limited and Apotex UK Limited [2008] EWCA Civ 445, (see
Here the form that was the subject of the subsequent patent actually lacked novelty over the form described in a previous patent. So evergreening is an issue where companies do effectively extend the monopoly of the initial patent. I know of situations where the subsequent 'composition' patent will essentially cover all pharmaceutical compositions that work. Countries like India believe that is unfair. They give an initial patent monopoly and then expect the drug to be available off-patent. However companies that try to evergreen are trying to sabotage that process.

Anonymous said...

Anonymous @ 15:47,

I think your answer begs the position that the first patent (or perhaps more accurately, what is claimed in the first patent) is in fact not becoming public domain at the end of the term.

That is not (strictly) a problem with evergreening. That is a problem with understanding what is - and what is not - covered by that first patent - coupled with a lack of enforcing the actual bargain of that patent. To put it directly, if something is covered by the claims of a patent, that something is part of the public domain after the patent term of exclusivity is over. Period. Where evergreenign comes in is that something else perhaps having a large and oh so very convenient overlap is covered by a different later expiring patent. But it is only the later expiring claimed aspects that is off limits with evergreening, and the item first covered is very much in the public domain.

Of course, this is a bit simplified, because I do recognize that actually determining what is and what is not covered may involve very expensive litigation efforts. But that too, is not a direct reflection of evergreening, as that expense and determination affects ALL patents.

Anonymous said...

There cannot be a sensible discussion on evergreening because it does not exist, although many believe it does. Once a thing has been patented, that thing is available for public use on patent expiry. The same thing cannot be re-patented and therefore not evergreened. Improvements of the thing can be patented, but they are different things and therefore not an evergreened original thing.

Of course, the objection to evergreening, or to be factually correct, the opposition to patents for improvements in pharmaceuticals, comes from the greedy and or/ignorant.

As for the Servier case, probably another case of bad examination. The examiner could have asked for evidence supporting novelty. Also, even when granted, interested parties are more than capable of performing a few experiments to determine novelty, and although there is the pain of launching revocation proceedings, this provides a potential opportunity for a competitive advantage.

Anonymous said...

This link provides Robin Jacobs' comments on pharma and evergreening:
He is talking about evergreening with 'bad' patents. But there is also evergreening with 'good' patents. Should that be allowed in the pharma sector by all territories, even if it's against their national interests? That's an important question upon which there will inevitably be disagreement.

Anonymous said...

Robin refers to the Servier decision as support for the argument that examination cannot be improved. I disagree. The examiner had the right to say to Servier that the compound for which they are claiming a new crystal form was already known from the earlier case and that Servier had to provide evidence to distinguish their claimed form from that already known. Simple.

Anonymous said...

EP1869035B1. Claims a crystal form of old drug. On 6-2-2012 a third party submitted experimental evidence proving (?) the claimed form to be identical to that of the original patent disclosure, hence lacking novelty. Same position as Servier example. On 2-5-2012 EPO sent communication of intent to grant.

No objection made or explanation from applicant requested.

Care to discuss anyone? Especially from the EPO

Anonymous said...

My important comment (yes!) above has been passed over due to the recent delay in comment-posting and the numerous tit-for-tat bickering that has occurred.

On a more general note - too many blogs with ongoing discussions suffer with the conveyer-belt of doom approach. Can live discussions not bring these blogs back to the surface?

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